Who Should Attend

This course will benefit those involved in the monitoring and/or QA of clinical trials.  Employees who work for Pharmaceutical firms, Contract Research Organizations, Medical Device companies and academic institutions involved with the supervision or oversight of clinical trial practices and policies will find this course of interest.



Learning Objectives

Upon completion, attendees will be able to:

• Identify and define the principles and requirements for GCPs
• Define the basic roles and responsibilities of sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials
• Understand how GCPs can impact clinical research progress and ensure that GCPs are implemented
• Clearly put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
• Ensure that your data and supporting documentation are accurate and presentable for inspection
• Comply with informed consent and Human Subject Protection requirements
• Learn how to detect and prevent fraud and misconduct in clinical trials
• Learn how to manage a FDA GCP inspection 

Course Description

This training course provides a solid understanding of GCP requirements and clinical quality assurance overviews for clinical trials.  Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites.  This course teaches participants how to ensure that their data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities.  Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and interactive case studies.



View Course Agenda




Past Participant's Comments:

“The course director was very knowledgeable about the course subject.  Reading existing examples from the FDA audit was very useful.  This was one of the better courses I have been to, and I will recommend this course to my colleagues..” 
Ainars S., Project Manager, JSC Grindeks

“The Course Director was extremely knowledgeable and was able to convey that knowledge to the class.  He didn’t talk over us, but to us.” 
Susan T., Senior Manager, Clinical Research, Cephalon

“The course director was an outstanding choice for an instructor for this course.  He instills confidence that CfPIE has its fingers on the pulse of national & international regulatory & GCP compliance issues.”
Paul L., Director, Research Operations, New Health Sciences

“The course director was extremely knowledgeable about the course subject.  I will definitely recommend this course to others.”
Sue B., Clinical Documentation Coordinator, Sanofi Pasteur

“The Course Director was very engaging.  He is very knowledgeable in all aspects of clinical study monitoring and answered all of the questions asked.  I feel much better knowing some background on this topic.”
Elizabeth W., Clinical Applications Specialist, Cochlear Americas